US $1.6M HEPATITIS B VACCINE TRIAL IN GUINEA-BISSAU SPARKS GLOBAL OUTCRY OVER ETHICS

A controversial $1.6 million vaccine study funded by the United States in Guinea-Bissau has drawn intense criticism from global health experts, who argue the plan is “highly unethical” and could undermine trust in lifesaving immunisation programs.

The controversial research, backed by the US Centers for Disease Control and Prevention (CDC), plans to follow tens of thousands of newborns in the West African country — where hepatitis B infection rates are among the world’s highest — to assess outcomes related to the timing of the hepatitis B vaccine. The study’s design involves some infants receiving the vaccine at birth while others will not. Critics argue that withholding a proven, safe vaccine in a high-risk region raises serious ethical concerns.

Experts have condemned the trial as reflective of a “neocolonialist” approach to global health research, especially as the CDC recently shifted its domestic guidance on hepatitis B vaccination — a move that has already fueled controversy and vaccine hesitancy.

Renowned public health figures argue that the vaccine’s safety and effectiveness are already well established and that the research does not offer a clearly defined scientific question that justifies withholding the shot in a vulnerable population. Some have questioned the lack of a competitive grant process and the absence of rigorous ethical review typical of clinical trials.

The study is slated to begin before Guinea-Bissau implements universal birth-dose vaccination in 2027, adding to fears that the research could exacerbate mistrust of vaccines across Africa and beyond. Public health advocates stress that efforts should instead focus on increasing vaccination coverage and strengthening fragile health systems.

WHAT CRITICS ARE SAYING
● Health specialists warn that conducting such research in a nation with a fragile healthcare system and extremely high disease prevalence risks expanding global mistrust of vaccines.

● Some experts note that the randomized design — where infants are not equally protected — could contradict long-standing international recommendations for universal birth-dose hepatitis B immunisation.

● Concern has also been raised that political motives, including recent shifts in US vaccine policy, may influence scientific priorities.

GLOBAL IMPLICATIONS
Public health officials worry the backlash could have broader consequences for vaccine confidence, particularly in low-income countries. The controversy highlights ongoing debates about research ethics, international health equity, and the legacy of Western involvement in African medical research.